Obesity, Overweight
Conditions
Keywords
overweight, obesity
Brief summary
This is a six month lifestyle management study to compare the effects of iWell; a dynamic online interactive technology to a self-directed program in overweight or obese individuals. The primary aim is to test the hypothesis that dynamic online interactive technology intervention is more effective than self-directed program in obtaining and maintaining weight loss and other biometric improvements.
Detailed description
Optimal health behavior is difficult to sustain over extended periods. This study seeks to demonstrate that technology can be a low cost scaleable solution that will provide the user with sufficient customization and personalization through social networking approaches such that sustainability of optimal health behavior is realized.
Interventions
BEHAVIORALTechnology assisted health behavior
Web-based interactive program using an hpod sensor that tracks physical activity as well as biometric parameters into the iWell server and is transmitted to the internet site via the users PC. Also serves as a social networking site.
BEHAVIORALSelf directed
Receives support and encouragement with minimal contact. Receives printed lifestyle guidelines with diet and physical activity recommendations.
Sponsors
PeaceHealth Laboratories
SK Telecom Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* age 18-70 years old * overweight or obese men and women with BMI between 24 and 38, inclusive * concerned about weight/health (and motivated in losing weight) * stable medications for past 3 months * willing/able to use Web-based services * willingness not to use weight loss medications for the duration of the trial * able and willing to give informed consent and participate in the interventions * willing to come to three sessions and visits * willingness to be randomized to intervention or control group
Exclusion criteria
* contraindication to weight loss (e.g., malignancy or other serious illness) * Type 1 DM and Type 2 DM with other end organ compromise (renal, retinal or other) * Recent (within 6 months) cardiovascular event (MI or stroke) * current symptoms of angina * heart, renal, or liver disease (excluding kidney stone) * cancer or active neoplasm (excluding skin cancers) * hyperthyroidism * mental conditions that would preclude full participation * prior weight-loss (bariatric) surgery or plan for these procedures * liposuction surgery in past 12 months or plan for these procedures * recent weight loss in the past 3 months (\>20 lbs) * use of prescription weight loss medication in 3 months prior to screening * current use of medications for treatment of psychosis or manic-depressive illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss from baseline | at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure change from baseline | at 3 months | Systolic blood pressure and diastolic blood pressure |
| Triglyceride level change from baseline | at 3 months | Participants will have a venous draw to determine Triglyceride levels |
| High density lipoprotein level change from baseline | at 3 months | Venous draw to determine high density lipoprotein levels |
| Physical activity adjustment from baseline | at 3 months | Standardized activity questionaire and activity monitoring device will be used to determine adjustments in activity for each arm |
Countries
United States
Outcome results
None listed